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Associate Regulatory Affairs

eTeam Inc
Job LocationUxbridge
EducationNot Mentioned
Salary£14.00 per hour
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract, full-time

Job Description

Job Tite: Associate Regulatory AffairsJpb Duration: 12 MonthsJob Location: Cambridge, Uxbridge, UK Proposed FieldGlass job description:

  • The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trials in the EU.
  • Over time the scope could expand to also support other regulatory activities like post-approval variations, annual reports, pre-MAA filing or regulatory authority meeting preparations.
  • In collaboration with Regional Regulatory Lead create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications.
  • Ensure compliance via timely submissions to regulatory agencies. Coordinate collection of functional documents in support of regulatory applications.
  • Coordinate QC of regulatory documentation (e.g. briefing packages).
  • Prepare regulatory packages and cross-reference letters to support investigator initiated studies.
  • Complete regulatory forms to support agency communications (e.g. EudraCT).
  • Support process improvement initiatives, standards development, and metrics.
  • Assist in template development and maintenance.
  • Actively support regulatory compliance.
    • Key Skills: Good communication skills - oral and written.Organizational skills. Understanding of drug development process. Previous experience in pharmaceutical industry of at least 1 year is preferred, ideally in a regulatory affairs department. Required skills
  • assist in the creation and submission of regulatory documents
  • pre-MAA filing or regulatory authority meeting preparations
  • Coordinate QC of regulatory documentation

    • Keyskills :
    assist in the creation and submission of regulaty documents pre-MAA filing regulaty authity meeting preparations Codinate QC of regulaty documentation

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